This newsletter serves as a digest of the latest announcements and stories out of CTP. It is a complement to our Spotlight on Science newsletter and CTP News e-blasts.
In This Issue…
Ten years ago, the Tobacco Control Act was signed into law, and from the act, CTP was born. In the last 10 years, CTP has grown from two staff members to about 800. Each day, these hundreds of CTP professionals, across a wide range of disciplines, work together to regulate tobacco products in the common mission of reducing the death and disease toll from tobacco. Through rigorous research, attentive oversight for legal compliance, and science-based public health education, CTP regulates a complex and rapidly changing tobacco landscape.
For example, FDA recently finalized a guidance document outlining FDA’s enforcement policy on the unauthorized marketing of flavored cartridge-based e-cigarettes that appeal to children and do not have premarket authorization from FDA. The President also signed legislation recently raising the minimum legal age to purchase tobacco products from 18 to 21.
In this first CTPConnect issue of 2020, read about CTP’s recent important actions in fulfilling the center’s public health mission of protecting people, and particularly youth, from the harms of tobacco use.
Enforcement Policy, Legislation Take Aim at Youth E-Cigarette Use
- FDA Finalizes Enforcement Policy on Unauthorized Flavored Cartridge-Based E-Cigarettes That Appeal to Children
- Legislation Raises Minimum Legal Age to Buy Tobacco Products From 18 to 21
Regulations and Product Reviews
- FDA Authorizes First Modified Risk Tobacco Products for U.S. Market
- Cigarettes Authorized That Contain Reduced Nicotine Levels Compared to Typical U.S. Cigarettes
- FDA Streamlines Its “Grandfathered Tobacco Product Status Determination Program”
- FDA Issues Draft Guidance for Submission of Plans for Cigarette Packages, Ads
- Materials Posted from Pubic Meeting on Deemed Tobacco Product Applications
Compliance and Enforcement
- CTP Compliance Report Highlights Five Years’ Activities
- FDA Explains Policy on Limited Modifications to Battery-Operated Tobacco Products, E-Liquids
- FDA Warns Company Selling Nearly 100 Illegally Marketed Flavored E-Cigarette Products
- Updated Webinar for Industry: Data Submission for User Fee Calculations
- Feature Article: Q&A With the CTP Office of Compliance and Enforcement’s Ann Simoneau
Informational Materials on Youth E-Cigarette Use, Addiction, and More
- “My Vaping Mistake” Videos Expand FDA’s Youth E-Cigarette Prevention Campaign
- FDA-Scholastic Collaboration on Teen E-Cigarette Prevention Materials
- Feature Article: Freedom of Information Act Protects Citizens’ “Right to Know”
Did You Know…?
ENFORCEMENT POLICY, LEGISLATION TAKE AIM AT YOUTH E-CIGARETTE USE
FDA Finalizes Enforcement Policy on Unauthorized Flavored Cartridge-Based E-Cigarettes That Appeal to Children
On Jan. 2, FDA issued a final guidance outlining its policy prioritizing enforcement of the premarket review requirements for certain flavored e-cigarette products, including fruit and mint flavors, that appeal to kids. Under the policy, which is described in an FDA news release, companies that do not cease the manufacture, distribution, and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days of the issuance of the policy risk FDA enforcement action.
The finalization of this enforcement policy has occurred as the National Youth Tobacco Survey shows alarming rates of youth e-cigarette use in 2019. (See “2019 NYTS: Epidemic Levels of Youth E-Cigarette Use.”)
On Aug. 8, 2016, all e-cigarettes and other electronic nicotine delivery system (ENDS) products became subject to FDA’s tobacco authorities, including the premarket review and authorization requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act). All e-cigarettes and other ENDS products on the market at that time needed to have authorization from FDA to be legally marketed. However, as part of a continued compliance policy, the agency had deferred enforcement of the premarket review and authorization requirements. To date, no ENDS products have been authorized by FDA—meaning that all ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time, in FDA’s discretion.
Beginning Feb. 6, FDA intends to prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization:
- Any flavored, cartridge-based ENDS products (other than a tobacco- or menthol-flavored ENDS product);
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
- Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.
“By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth,” said HHS Secretary Alex Azar. “We will not stand idly by as this crisis among America’s youth grows and evolves, and we will continue monitoring the situation and take further actions as necessary.”
2019 NYTS: Epidemic Levels of Youth E-Cigarette Use
Middle and high school students used e-cigarettes at disturbingly high rates in 2019, according to the National Youth Tobacco Survey, released recently by FDA and CDC. More than 5 million youth reported having used e-cigarettes in the past 30 days and nearly one million reported daily use. While cigarette smoking among high school students is at an all-time low, increases in e-cigarette use have reversed progress made in terms of declining overall tobacco use by youth.
For additional information about NYTS, including a graphic summarizing important findings in the most recent survey, visit CTP’s Youth Tobacco Use: Results From the National Youth Tobacco Survey webpage.
On Dec. 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21. It is now illegal for a retailer to sell any tobacco product, including cigarettes, cigars, and e-cigarettes, to anyone under the age of 21.
FDA recognizes that both the agency and some retailers will need to update current practices to implement this new law. During this period of transition, the agency expects retailers to follow the law and take measures to ensure an individual purchasing a tobacco product is 21 or older, including manually checking IDs when needed.
The agency offers free resources to assist retailers in calculating the age of customers. Retailers who use FDA’s “This Is Our Watch” digital age verification calendar may update the minimum purchase age on the calendar to 21 years. Instructions on how to update the age on the digital calendar are available on FDA’s website. Retailers who would like a “This Is Our Watch” digital age verification calendar may order a calendar free of charge from the CTP Exchange Lab. For retailers who use FDA’s Age Calculator app, the age limit can be updated to 21 years through the app settings. The app’s “help” feature provides instructions.
FDA will provide additional details on this issue as they become available.
REGULATIONS AND PRODUCT REVIEWS
When the Tobacco Control Act was signed into law in 2009, it became illegal for companies to market their tobacco products with certain claims, such the product presents a lower risk of tobacco-related disease than other commercially marketed tobacco products, except where specifically authorized by an FDA marketing order. To obtain an order to market a product as a “modified risk tobacco product” (MRTP), tobacco companies must first demonstrate to FDA that a proposed modified risk product will, or is expected to, benefit the health of the U.S. population as a whole—including adults and children, and tobacco users and nonusers.
On Oct. 22, FDA for the first time authorized the marketing of products through the MRTP pathway. The authorizations are for eight Swedish Match USA Inc. snus smokeless tobacco products sold under the “General” brand name. This action allows the products to be marketed with the modified risk claim, “Using General Snus instead of cigarettes puts you at lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” The decision does not mean, however, that these products are safe or “FDA approved.” All tobacco products are potentially harmful and addictive, and those who do not use tobacco products should continue to refrain from using them.
The modified risk orders are product-specific and limited to five years. FDA authorized the marketing of the products with modified risk claims after reviewing scientific evidence submitted by the company that supports the specific lower-risk claim. “Today’s action demonstrates the viability of the pathway for companies to market specific tobacco products as less harmful to consumers, but only following a thorough scientific evaluation by FDA,” said CTP’s director, Mitch Zeller. Toward preventing youth access and exposure, the agency has placed stringent advertising and promotion restrictions on the products. An FDA news release provides additional information.
FDA has issued marketing orders to 22nd Century Group Inc. for two new tobacco products, Moonlight and Moonlight Menthol combusted, filtered cigarettes, that contain reduced nicotine levels compared to typical cigarettes marketed in the United States. The authorization followed FDA’s comprehensive review of available scientific evidence relevant to the company-submitted premarket tobacco product applications (PMTAs) that supported a determination by the agency that marketing of these products would be appropriate for the protection of public health.
The newly authorized cigarettes may reduce nicotine exposure and cigarette consumption, as discussed further in an FDA news release. The issuance of marketing orders allows the two tobacco products to be legally sold or distributed in the United States, but it does not mean the products are safe or “FDA approved”—there are no safe tobacco products. This action is not related to the modified risk tobacco product applications submitted by 22nd Century Group Inc., which are currently under review by FDA.
A grandfathered tobacco (GF) product is a tobacco product commercially marketed (other than exclusively in test markets) in the United States as of Feb. 15, 2007. Grandfathered products are regulated under the Food, Drug, and Cosmetic Act (FD&C Act) but are not considered new tobacco products and do not require premarket authorization to be legally marketed. Firms may voluntarily submit requests for grandfathered status determinations, although such submissions are not required under the FD&C Act.
FDA has observed, over years of reviewing “standalone grandfathered status determination requests,” that many of these requests do not include sufficient information for the agency to make the status determination. To allow the agency to better use its resources and support more productive, timely responses to industry in this area, FDA will issue “Unable to Accept” and “Unable to Review” letters to industry under certain circumstances.
A new CTP webinar, “Voluntary Standalone Grandfathered Tobacco Product Status Determination Program,” explains GF tobacco products and provides tips on how to successfully submit a request. On CTP’s website, you can find additional information about updates to the GF status determination program and more broadly about the regulation of Grandfathered Tobacco Products.
FDA has issued a draft guidance to help those required by law to submit cigarette plans for cigarette packages and cigarette advertisements. Submission of this type of plan is outlined as a marketing requirement within FDA’s “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements” proposed rule published in August 2019.
The draft guidance, “Submission of Plans for Cigarette Packages and Cigarette Advertisements,” provides recommendations related to these plans submitted to FDA detailing how the proposed required warnings would be displayed on cigarette packages and rotated on cigarette advertisements. Among the information addressed in the draft guidance: who should submit these plans, when, and with what information.
FDA has posted materials from its Oct. 28–29, 2019, public meeting on the tobacco product application review process with a particular focus on deemed tobacco products.
COMPLIANCE AND ENFORCEMENT
A new Compliance and Enforcement Report summarizes the activities of CTP’s Office of Compliance and Enforcement (OCE) between Oct. 1, 2013, and Dec. 31, 2018. OCE’s efforts help ensure that regulated industry and regulated tobacco products are in compliance with the laws designed to protect the public health generally and to prevent tobacco use by minors. This five-year period covered in the report included turning points such as finalization in 2016 of the landmark “deeming rule,” which broadened the scope of FDA’s tobacco regulatory authority, and the announcement in 2017 of FDA’s “Comprehensive Plan for Tobacco and Nicotine Regulation” focusing on the issue of nicotine and addiction. Within this time period, as well, research revealed a disturbing number, and upward trajectory, of youth using e-cigarettes.
The report summarizes OCE’s activities aimed at protecting youth, as well as adults, from tobacco-caused disease and death, providing a sense of the office’s critical contributions to the center’s mission of preventing people from starting to use tobacco products, encouraging tobacco users to quit, and ultimately reducing the harm caused by tobacco use. These compliance and enforcement efforts complement other critical CTP activities, and represent important strides in public health protection, noted CTP’s director, Mitch Zeller. Still, the center director emphasized, “We at CTP are always mindful that these recent efforts, like those of prior years, serve not only as protective public health achievements in their own right, but also as the foundation for a great deal of work that remains to be done.”
FDA has issued a guidance, Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products, that sets out the agency’s compliance policy related to limited safety modifications for certain tobacco products intended to ensure the public is protected from risks such as battery explosions or accidental exposure to toxic levels of nicotine. The guidance provides clarity to manufacturers considering these limited safety-related modifications to their electronic nicotine delivery system products to address a voluntary industry battery standard and comply with requirements related to safe packaging (“flow restrictors”) for liquid nicotine products. An FDA In Brief provides additional information about the guidance.
FDA issued a warning letter last October notifying a tobacco company that nearly 100 of its flavored products were being marketed illegally, without the required authorization. The company, Eonsmoke LLC, violated the law by marketing new tobacco products without premarket authorization, including e-liquids in flavors such as mango, cotton candy, and sour gummy worm.
The warning letter also noted that the company was violating the law by advertising products online and through social media without the required nicotine warning statement “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”
An FDA In Brief provides additional information about the warning letter and the various underlying violations.
FDA has updated its tobacco compliance webinar titled “User Fees—Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products.” The video provides an introduction to tobacco product user fees and the data that has to be submitted by manufacturers and importers to assist FDA in making user fee assessments. Coverage includes FDA’s tobacco product user fee authority, the user fee process, and what information to submit. Importantly, as noted in the webinar, cigars and pipe tobacco are subject to user fees following issuance of the deeming rule, in addition to cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco.
Learn about the Office of Compliance and Enforcement from the unique vantage point of the office’s director, Ann Simoneau. What does the office do and why is its work important to public health? What accomplishment is she most proud of as the office’s director, and what does she view as the greatest current challenge? How has her office responded to the challenges associated with e-cigarettes?
INFORMATIONAL MATERIALS ON YOUTH E-CIGARETTE USE, ADDICTION, AND MORE
FDA has launched a video series called “My Vaping Mistakes” as part of its “The Real Cost” Youth E-Cigarette Prevention Campaign. The four-episode series, being released throughout January 2020 on the Awesomeness TV YouTube channel and on “The Real Cost” social media, features teens’ true stories of the physical and emotional effects of e-cigarette addiction. “These powerful narratives from youth show their peers the disastrous impact of e-cigarette addiction, like the teens who developed severe anxiety and depression after using e-cigarettes or the high school athlete who could no longer compete,” said FDA Commissioner Stephen M. Hahn, MD, in a statement announcing the videos.
Since 2018, FDA has collaborated with the global children’s publishing, education, and media company Scholastic to create educational resources for teachers to address the e-cigarette epidemic in schools. Key players from the two organizations answer questions in a new feature article.
In an example of this important collaboration, FDA and Scholastic recently developed new resources to supplement materials already offered to middle and high schools in support of their youth e-cigarette prevention efforts. The resources include new materials for middle schools, along with updated materials for high schools.
Given the numbers of middle and high school students using e-cigarettes in 2019, as shown by the 2019 National Youth Tobacco Survey, educators have an active role to play in fighting the epidemic of youth e-cigarette use. FDA research suggests that, when teachers talk about the health consequences of e-cigarettes and schools enforce anti-vaping policies, students may be less likely to use e-cigarettes.
Resources such as lesson plans and activity sheets will be sent to more than a million middle school and high school teachers to help them start educational conversations about the harms of youth e-cigarette use. Also, on the Scholastic-created “The Real Cost of Vaping” website, additional materials are available to help educate youth about the dangers of e-cigarette use, including a parent take-home sheet, infographics, youth cessation resources, and an educational program that can be used by schools as an alternative to student suspensions or citations. And more FDA and Scholastic resources are in development and expected to be available in spring 2020.
“One of the critical ways FDA can work to curb youth e-cigarette use is by continuing to educate teachers, as well as parents and youth themselves, about the dangers of e-cigarette use,” said CTP’s director, Mitch Zeller, J.D. “Last year, we joined forces with Scholastic to develop and distribute educational resources to high school educators across the country. And this year, we are expanding our collaboration to include middle school educators, as we strive to reach even more youth who have tried, or are considering trying, e-cigarettes.” Details are available in an FDA In Brief.
The Freedom of Information Act (FOIA) empowers people to request documents from CTP to help them understand the center’s decision-making process. Information is generally releasable, with nine exemptions set forth under the law, as detailed in this feature about CTP’s FOIA office and activities.
DID YOU KNOW…?
If your New Year’s Resolution for 2020 was to quit smoking—whether it’s your first try or not—don’t give up, and remember that even small steps are wins. You may be able to go longer without a cigarette than the last time you tried. Or you might discover new techniques, such as exercise, that could help stave off your cravings and move you one step closer to being able to call yourself a “former smoker.”
Visit FDA’s Every Try Counts webpage for information about the agency’s public education campaign to help adult cigarette smokers quit. If you are looking for campaign resources, visit everytrycounts.gov for quitting tools and information for yourself or to share with friends, family, and community.